Common use of Technology Transfer Clause in Contracts

Technology Transfer. Subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo.

Appears in 3 contracts

Samples: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.), License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.), License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)

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Technology Transfer. Subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s 's expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s 's written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s 's written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo.

Appears in 2 contracts

Samples: License and Collaboration Agreement (Medicines Co /De), License and Collaboration Agreement (Medicines Co /De)

Technology Transfer. Subject As described in the IPDP, Awardee will be transferring technology to two Sub-Awardees (IDT and an LMIC manufacturer) and the terms costs of such technology transfers are included in the Project Budget. Awardee will promptly and diligently provide all necessary guidance, information, materials and assistance reasonably required to transfer Awardee’s technology to each such Sub-Awardee as outlined in the IPDP. Pursuant to an Outbreak Notice, CEPI may request to accelerate the timelines for transfer of Awardee’s technology to one or both of such Sub-Awardees and/or CEPI may request an expansion of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCoanother Trusted Collaborator (other than such Sub-Awardees) if that would achieve the transfer more quickly. If CEPI requests transfer of Awardee’s technology to another Trusted Collaborator, Awardee will promptly and diligently provide all necessary guidance, information, materials and assistance reasonably required by such Trusted Collaborator to accomplish the activities that may be requested by CEPI under Clause 16.2 or to its Third Party manufacturer(s16.3 (“Technology Transfer”) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for at CEPI’s cost. Awardee shall carry out the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect Technology Transfer to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject other Trusted Collaborator pursuant to the terms and conditions of a to-be-agreed-upon confidentiality agreement in accordance with this Agreement to be entered into between Awardee and the Trusted Collaborator governing the Trusted Collaborator’s use and non-disclosure of information and materials provided in connection with the Technology Transfer, provided that Awardee and the Trusted Collaborator shall not delay the execution of such agreement. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignmentMARKED BY BRACKETS, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignmentIS OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) CUSTOMARILY AND ACTUALLY TREATED BY THE REGISTRANT AS PRIVATE OR CONFIDENTIAL. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo.ANNEX A: TERMS AND CONDITIONS – SCHEDULE A

Appears in 2 contracts

Samples: ghiaa.org, Valneva SE

Technology Transfer. Subject In the event that QIAGEN is unable to supply the Product in accordance with any purchase order, or otherwise in accordance with the terms of the Development Supply this Agreement, within sixty (60) days after the firm delivery date for such purchase order, then upon ArcherDX's written request QIAGEN shall (i) grant to ArcherDX, and hereby grants to ArcherDX, a worldwide, royalty-free (except royalty-bearing licenses from third parties in effect and disclosed to ArcherDX in advance of such license grant) non-exclusive right and license, with the right to grant sublicenses solely for the purpose of complying with technology transfer obligations under the Third Party agreements, under all relevant, QIAGEN intellectual property to make, have made, use, import and export Products; and (ii) provide, or release from Escrow, to ArcherDX or its designee (which may include another manufacturer or a Third Party to a ArcherDX agreement) with all assistance and materials, including but not limited to SOPs, formulations, know-how, processes, batch records and other documents and materials as soon as ArcherDX may reasonably practicablerequest, but to enable ArcherDX or a Third Party to manufacture the Products, provided that QIAGEN shall not be obliged to expense more than 160 hours of working time for such assistance. Notwithstanding the foregoing, ArcherDX shall use commercially reasonable efforts not to accept technology transfer obligations in no event later than future Third Party Agreements. Each of ArcherDX and any Third Party that ArcherDX designates to manufacture the fifth (5th) anniversary Products must also agree in writing with QIAGEN to observe the terms of this Agreement relating to confidentiality of Products and QIAGEN's proprietary rights and information transferred pursuant to this Section 2.14, in particular, the Effective Date, Alnylam shall initiate identification and protection of QIAGEN trade secrets. ArcherDX or its designee may continue to exercise the licensed rights provided in this Section 2.14 only until QIAGEN notifies ArcherDX that it is again able to supply ArcherDX's Products requirements and has successfully delivered Products from two consecutive purchase orders after such notification in full conformity with this Agreement. If a technology transfer to MedCoprovision is invoked in an agreement by ArcherDX, or to its and at the request of the Third Party manufacturer(s) of Licensed which invoked the technology transfer provision, QIAGEN shall use commercially reasonable efforts to enter into an agreement to supply Product, selected by MedCo and reasonably acceptable on essentially equal terms as, to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of other party in the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoAgreement.

Appears in 2 contracts

Samples: Supply and Manufacturing Agreement (ArcherDX, Inc.), Supply and Manufacturing Agreement (ArcherDX, Inc.)

Technology Transfer. Subject to the terms of Upon determination by the Development Supply AgreementCommittee that a Product based on a Feasible Prototype is ready for commercialization, as soon as reasonably practicable, Cxxx will have the option but in no event later than not the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer obligation to MedComanufacture such Product, or to its Third Party manufacturer(shave such Product manufactured by a third party. Cardica will continue to supply to Cxxx, upon Cxxx’x request and at a cost of [*] per unit, such additional units of the Product over the [*] units described in Section 5.2(C) above as Cxxx may reasonably request for the further testing [*] = CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. WITH RESPECT TO ATTACHMENT A, SIX PAGES OF INFORMATION HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. and development of Licensed the Product. Upon the first FDA Approval of a Product in the Field that is based on a Feasible Prototype that the Development Committee determines is ready for commercialization, Cxxx will have the sole responsibility for manufacturing such Product, selected by MedCo or having such Product manufactured, at its sole expense. Upon Cxxx’x request, to enable Cxxx to assume such responsibility, Cardica will transfer to Cxxx, at no additional cost, all equipment, including all pre-production tooling, and reasonably acceptable to Alnylam, of Alnylam Cardica Know-How How, including but not limited to, all trade secret, manufacturing and supplier information included therein, related to the Products that is reasonably necessary or useful for Cxxx to manufacture such Product (“Transferred Product”). Upon request from Cxxx, Cardica will provide, at no additional cost, reasonable technical assistance to Cxxx for the Manufacture Transferred Product based on the mutual availability of the Licensed parties, which assistance may include: i) training of Cxxx personnel in connection with the manufacture of Transferred Product, ii) advice concerning the manufacture of Transferred Product, and shall make available its personnel iii) testing of sample Transferred Product to verify that such Transferred Product complies with applicable specifications established by the Development Committee to confirm successful transfer of technology to Cxxx hereunder. Additionally, on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written Cxxx’x request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to parties will negotiate the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement under which Cardica may provide engineering services to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided assist Cxxx in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (design and any other Third Party manufacture modification of Transferred Product to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product meet customer and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoregulatory requirements.

Appears in 1 contract

Samples: Agreement (Cardica Inc)

Technology Transfer. Subject Upon UGNX’s request and subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful Transfer Restrictions, Mereo shall, in a timely manner conduct and cause its applicable CMOs to conduct, the transfer of the Manufacturing processes for the Manufacture Drug Substance, Licensed Product and placebo for the Licensed Product (each a “Material” and collectively, “Materials”) to one or more CMOs designated by UGNX to allow establishment and validation of the Licensed ProductManufacturing process for the Materials (the “Technology Transfer”), which may include Mereo authorizing its current CMOs to Manufacture the Materials for UGNX using the same processes and activities conducted for Mereo. Such Technology Transfer shall make available include any Manufacturing processes and technology transferred by Novartis (or its personnel on a reasonable basis CMO(s)) to consult with MedCo Mereo (or such Third Party manufacturer(sits CMO(s)) with respect theretoto the Drug Substance or Licensed Product. Mereo shall bear solely its own internal Costs, all at MedCo’s expenseand UGNX shall reimburse Mereo for its out-of-pocket Costs (such as amounts payable to CMOs or other Third Parties), including the Costs reasonably incurred by Alnylam in connection with or on behalf of Mereo or its Affiliates to conduct such technology transfer activitieson Mereo’s behalf. MedCo shall reimburse Alnylam such Costs incurred with respect The Parties will develop and agree on a transition plan to such Manufacturing technology facilitate the Technology Transfer, including, where applicable, to transfer the oversight of the CMO and contract testing labs from Mereo to UGNX (the “Technology Transfer Plan”) within [***] days after receipt following the Effective Date (or such other timeline as may be mutually agreed by the Parties). The Technology Transfer Plan will set forth the roles and responsibilities of an invoice thereforeach Party, and each Party shall perform the activities assigned to it in accordance with the Technology Transfer Plan, consistent with the standards and timelines set forth therein. Alnylam The Parties will coordinate their Manufacturing activities under the Core Development Plan on a monthly basis via teleconference or in person, or more frequently as necessary, to ensure consistent Manufacturing strategies between the Parties and its Affiliates shall keep complete to coordinate Technology Transfer. Prior to conducting any Technology Transfer activities and accurate records in sufficient detail subject to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one applicable Third Party manufacturer for each stage Auditing Restrictions, UGNX shall have the right, upon prior written notice to Mereo, to conduct a Manufacturing/GMP data audit of the Licensed Product supply chain (i.e.Manufacturing, Bulk Drug Substancequality control testing and quality assurance release history and records, Bulk Drug Product all process and Finished Product)method development reports, characterization reports, stability and quality control testing reports. Promptly after MedCoMereo shall reasonably coordinate with UGNX to conduct such audit. UGNX’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture conduct of Licensed Products. Such assignment such audit shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the confidentiality obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting consistent with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as those set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoherein.

Appears in 1 contract

Samples: Collaboration and License Agreement (Mereo Biopharma Group PLC)

Technology Transfer. Subject to the terms of the Development Supply Agreement, as As soon as reasonably practicablepossible, but in no event later than five (5) business days after the fifth Effective Date of this Agreement, Xxxxx & Nephew shall begin disclosing to ArthroCare all technology and know-how necessary to manufacture each of the Licensed OEM Products listed on Exhibit A-S and each of the Sculptor Products listed on Exhibit B-S and shall provide ArthroCare with all assembly and component drawings, specifications, manufacturing process information, tooling, fixtures, molding, raw materials, and other equipment necessary to manufacture such Licensed OEM Products and Sculptor Products (5th) anniversary the “Technology Transfer”). The Parties shall cooperate in good faith and use reasonable commercial efforts to complete the Technology Transfer in sufficient time to permit ArthroCare to manufacture the quantities of ArthroCare Manufactured Products ordered by Xxxxx & Nephew as of the end of the Transition Period. ArthroCare shall provide Xxxxx & Nephew an estimated budget and schedule for completion of the Technology Transfer. ArthroCare shall use commercially reasonable efforts to meet such estimated budget and schedule, provided that ArthroCare shall not be liable or be deemed in breach of this Agreement solely for failing to meet such estimated budget or schedule. The schedule shall require completion of the Technology Transfer and manufacturing commencement within [*] of the Effective Date, Alnylam . ArthroCare’s estimated budget for such work shall initiate a technology transfer be limited to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo ArthroCare’s documented expenses directly and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam solely in connection with such technology transfer activitiesthe Technology Transfer and shall not exceed [*]. MedCo shall reimburse Alnylam such Costs incurred Xxxxx & Nephew grants (on behalf of itself and its Affiliates) to ArthroCare [*] license under Xxxxx & Nephew’s and its [*] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice thereforthe omitted portions. Alnylam Affiliates’ rights in patents and other intellectual property owned or licensed to Xxxxx & Nephew to manufacture the Licensed OEM Products and Sculptor Products solely for Xxxxx & Nephew and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any no other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCopurpose.

Appears in 1 contract

Samples: Supply and Distribution Agreement (Arthrocare Corp)

Technology Transfer. Subject Consistent with the principle of avoiding supply disruption and in accordance with the transition plan established pursuant to Section 15.3, Pfizer shall provide Adolor with any then-existing documentation, technical information and other Know-How, in the form and format in which such materials are maintained by Pfizer in the ordinary course of its business (provided that Pfizer shall use commercially reasonable efforts to provide such materials in a form and format useable by Adolor), that are necessary for the manufacture of Named Compounds and Licensed Products. Such documentation, technical information and other Know-How shall include: (a) copies of flow charts of the manufacturing procedures and work instructions related to manufacturing Named Compounds and Licensed Products, (b) a list of all equipment, including the source of the equipment, utilized in the production of Named Compounds and Licensed Products, (c) copies of all current specifications for Named Compounds and Licensed Products, (d) copies of all standard operating procedures for the manufacturing procedures to be transferred, (e) all environmental conditions necessary to manufacture Named Compounds and Licensed Products and copies of any existing external environmental impact studies based on the materials or methods employed in the manufacturing method to be transferred, and (f) such other documentation as the Parties may mutually agree, in each case of the foregoing subsections (a) through (f), that are necessary to manufacture Named Compounds and Licensed Products. In addition, prior to the terms effective date of termination, and for up to ** thereafter, Pfizer shall make available to Adolor, the reasonable assistance of Pfizer’s employees, and shall request that any external Third Party manufacturers be available, to support the transfer of the Development Supply Agreementmanufacturing technology to Adolor. Pfizer shall use commercially reasonable best efforts to ensure that these personnel will cooperate with Adolor in the implementation of the manufacturing technology until such implementation has been completed successfully. Adolor shall reimburse Pfizer or any of Pfizer’s Third Party manufacturers for all reasonable Out-of-Pocket Costs and Expenses incurred pursuant to this Section 15.3.1. Pfizer shall continue to supply Adolor after the effective date of termination with Adolor’s requirements of clinical and commercial quantities of Named Compounds and Licensed Products, pursuant to a supply agreement to be negotiated in good faith by the Parties on “commercially reasonable terms” which agreement will remain in effect until the earlier of (a) the ** of the effective date of termination, and (b) such time as Adolor or a Third Party manufacturer engaged by Adolor is capable of supplying Adolor with its requirements of clinical and commercial quantities of Named Compounds and Licensed Products, provided, however, that Adolor must use its commercially reasonable best efforts to supply or have supplied by a Third Party, Named Compounds and Licensed Products as soon as reasonably practicablepracticable after the effective date of such termination. Solely for purposes of this Section 15.3.1, but in no event later than “commercially reasonable terms” means, with respect to clinical supplies of Named Compounds and Licensed Products, Pfizer’s Manufacturing Costs for such supplies, and with respect to commercial supplies means Pfizer’s Manufacturing Costs plus a reasonable xxxx-up, which xxxx-up shall not exceed ** prior to the fifth (5th) first anniversary of effective date of termination, ** for the next year and ** the second anniversary of the Effective Dateeffective date of termination, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCothe Parties.

Appears in 1 contract

Samples: License and Collaboration Agreement (Adolor Corp)

Technology Transfer. Subject Within a reasonable period of time (not to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of exceed [REDACTED: Term] after the Effective Date, Alnylam Thera will provide SA with: (i) one copy of all the electronic documentation in CTD format filed with the Food and Drug Administration of the United States of America for the Product, except with respect to the documentation listed in Schedule 2.3, (ii) all the documentation exchanged with Regulatory Authorities in each of the Countries, and (iii) if requested by the Regulatory Authorities of a Country, samples of the Product, the Product in semi-finished form and/or the Compound or excipients . The subsections (i), (ii) and (iii) of this Article 2.3 shall initiate a technology transfer be altogether referred to MedCoas the “Transferred Technology”. The documentation exchanged with Regulatory Authorities in each of the Countries, if any, will not be provided to SA in CTD format and SA shall be responsible to convert such documentation in such format or any other format at the sole cost and expense of SA. Further, SA shall be solely responsible for the translating or having translated any of the documentation transferred to SA correctly. SA shall bear all responsibility for the accuracy of the translation and all of the costs and expenses of translating any document provided by Thera under this Article 2.3 for the purpose of making Regulatory Filings with Regulatory Authorities. Thera, or to its a Third Party manufacturer(s) designated by Thera and acting on behalf of Licensed ProductThera, selected by MedCo shall make certain of its employees who are knowledgeable about the Product and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed ProductTechnology reasonably available to SA for scientific and technical explanations, advice and shall make available related on-site support, if and to the extent reasonably requested by SA, supporting the filing of a MAA in connection with SA’s exercise of its personnel on a reasonable basis rights and obligations under this Agreement. All such Licensed Technology provided to consult with MedCo SA and all information and materials (in whatever form or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expensemedium), including the Costs reasonably incurred by Alnylam electronic documentation in connection CTD format filed with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam the Food and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage Drug Administration of the Licensed Product supply chain (i.e.United States of America for the Product, Bulk Drug Substancetransferred, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture disclosed by or on behalf of Licensed Products. Such assignment Thera hereunder shall be and remain Thera’s Confidential Information, subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoArticle 11.

Appears in 1 contract

Samples: Distribution and Licensing Agreement (Theratechnologies Inc.)

Technology Transfer. Subject 3.1 Initial Technology Transfer. Schedule D, attached hereto, identifies specific components of technology Controlled by Alnylam or its Affiliates that Alnylam believes may be reasonably required or useful to effect the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, Monsanto (or to its Third Party manufacturer(sdesignated Affiliate(s)) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How Intellectual Property that is reasonably necessary or useful for the Manufacture exercise of Monsanto’s rights under the Licensed Product, and shall make available its personnel on licenses granted pursuant to Section 2.1(a). Within a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within period of [**] following the Effective Date (the “Technology Identification Period”), Monsanto shall identify which specific components of technology listed in Schedule D that Monsanto wishes to receive under the technology transfer process described in this Section 3.1 and shall notify Alnylam thereof by identifying such desired components of technology in Schedule I attached hereto. As soon as reasonably practical, but in no event later than [**] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage end of the Licensed Product supply chain Technology Identification Period (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Productthe “Initial Technology Transfer Period”). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to deliver the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer documentation for each item as set forth in this Schedule I (which may be amended from time to time by mutual agreement of the Parties, the “Technology Transfer Plan”). During the [**] day period following the Initial Technology Transfer Period (the “Technology Transfer Definition Period”), the Parties will discuss and mutually agree upon the training processes and activities, and the requisite number of Alnylam personnel to conduct such activities, for each item set forth in the Technology Transfer Plan and amend the Technology Transfer Plan to include such training processes and activities and personnel commitment and budget for such activities (as described in Section 5.3) for 3.2 below). During the supply [**] month period following the completion of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. the Technology Transfer Definition Period (“Technology Training Period”), Alnylam shall use Commercially Reasonable Efforts to obtain make available to Monsanto such number of technical personnel as may be set forth in the Technology Transfer Plan to answer any questions or provide training and instruction as set forth in the Technology Transfer Plan concerning the items delivered pursuant to this Section 3.1, in connection with Monsanto’s Discovery, Development, Commercialization and Manufacture of Licensed Products hereunder. Upon Alnylam’s belief that it has completed its technology transfer activities under the Technology Transfer Plan, Alnylam shall so notify Monsanto in writing and no later than [**] days after receipt of such consent notice from Alnylam Monsanto shall notify Alnylam in a form reasonably acceptable writing as to MedCowhether or not Monsanto agrees that Alnylam has completed its technology transfer activities under the Technology Transfer Plan. If Monsanto fails to provide such notice to Alnylam within such time period, then Monsanto shall be deemed to agree that Alnylam’s activities under the Technology Transfer Plan are completed. In the event that Monsanto notifies Alnylam in writing within such time period that it does not agree that such activities have been completed, then the Parties will discuss the items in dispute and work in good faith to amicably resolve the situation as promptly as possible, but in no event later than [**] days after Alnylam’s receipt of Monsanto’s notice.

Appears in 1 contract

Samples: License and Collaboration Agreement

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Technology Transfer. Subject to Under the terms of the Development Commercial Supply Agreement, as soon as reasonably practicableGSK will have the right, but in no event later than the fifth (5th) anniversary at its election, to receive technology transfer from Gilead of the Effective Date, Alnylam shall initiate manufacturing processes for bulk ADV and Licensed Products used by Gilead's Third-Party suppliers [ * ] if GSK makes an election to manufacture either bulk ADV or finished Licensed Product either for China or for the GSK Territory as a technology transfer whole as provided herein. GSK may elect to MedCo, or to its Third Party manufacturer(s) of manufacture either bulk ADV and finished Licensed Product, selected by MedCo and reasonably acceptable to Alnylamor finished Licensed Product alone, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred each case with respect to China alone, and also with respect to the entire GSK Territory (less China, if GSK made such Manufacturing election for China prior to making such election for the entire GSK Territory). For an initial transfer of manufacturing processes as to which GSK has not elected to assume responsibility in the GSK Territory previously, GSK shall give at least [ * ] written notice to commence such transfer, and the Parties will complete transfer of all such relevant information to GSK within [ * ] after the date of commencement of transfer, subject to acceptance criteria as more fully set forth in the Commercial Supply Agreement. GSK shall [ * ] in relation to any such technology transfer. Such [ * ] shall comprise [ * ] Such [ * ] shall also be documented and subject to audit by GSK. For the avoidance of doubt, GSK shall remain obligated to purchase amounts of bulk ADV and Licensed Products for which it submits binding forecasts or orders pursuant to the Commercial Supply Agreement, notwithstanding any election it makes hereunder. If GSK separately exercises its right to manufacture hereunder with respect to China, and later with respect to the remainder of the GSK Territory (or vice versa), then Gilead shall only be obligated to provide GSK with technology transfer within [***of any improvements Controlled by Gilead to the manufacturing process earlier transferred to GSK that have been implemented by Gilead's Third-Party suppliers [ * ] days after receipt Similarly, if GSK separately exercises its right to manufacture hereunder with respect to bulk ADV, and later with respect to finished Licensed Products, then Gilead shall only be obligated to provide GSK with technology transfer of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail any improvements Controlled by Gilead to enable the payments payable hereunder manufacturing process earlier transferred to be determined. Alnylam GSK that have been implemented by Gilead's Third-Party suppliers [ * ] Except as expressly provided herein, Gilead shall not be required to perform provide further technology transfer to more than one Third for process changes that Gilead or its Third-Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCosuppliers develop or implement.

Appears in 1 contract

Samples: Licensing Agreement (Gilead Sciences Inc)

Technology Transfer. Subject to the terms of After the Development Supply AgreementTransfer Date, Lpath shall use Commercially Reasonable Efforts to promptly transfer to Merck as soon as reasonably practicablepractical, but in no event later than the fifth (5th) anniversary of the Effective Date***, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam all Lpath Know-How How, including any preclinical data, clinical data, assays and associated materials, protocols, procedures and any other information in Lpath’s possession or control, that is reasonably necessary or useful for to continue or initiate Development of, or in seeking Regulatory Approval for, Licensed Products. For clarity, Lpath shall at all times have the Manufacture right to retain reasonable quantities of the Licensed Producttangible materials (if any) within such Lpath Know-How, and shall make available its personnel on a reasonable basis may use them, and authorize others to consult with MedCo or such Third Party manufacturer(s) with respect theretouse them, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activitiesOcular Products or other products outside the Field. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam Merck shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam cooperate and a Third Party that is solely related to facilitate such transfer, and the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam Parties shall use Commercially Reasonable Efforts to obtain any complete such consent transfer within *** after the Development Transfer Date. Details shall be set forth in a form reasonably acceptable technology transfer plan to MedCobe agreed upon by the Parties (“Technology Transfer Plan”) which plan shall set forth agreed-upon steps for an adequate technology transfer and timelines therefore, an outline of which is attached to this Agreement as Schedule 3.7. In addition, and without limiting the generality of the foregoing, upon Merck’s request Lpath shall (i) promptly assign to Merck all applications and filings made with any Regulatory Authority solely applicable to the Development or Commercialization of Licensed Products in and for the Field (and not applicable to any Ocular Product or other product outside the Field), including any applicable IND and orphan drug designations with respect thereto, (ii) use ***CONFIDENTIAL PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. Commercially Reasonable Efforts to assign to Merck all agreements related solely to the conduct of any Clinical Trial in and for the Field with respect to Licensed Product and to seek any required Third Party consents therefor (provided that such Commercially Reasonable Efforts shall not require Lpath to make payments or provide other consideration to any Third Party in consideration therewith), and (iii) assign to Merck all agreements, if any, related solely to the manufacture, supply or distribution of clinical supplies of Licensed Product for Clinical Trials in the Field (to the extent such agreement is specific to Clinical Trials in the Field, and not related to Ocular Products or other products outside the Field). For clarity, notwithstanding the foregoing, Lpath shall have the right to retain, and shall not be required to assign to Merck, (A) any applications and filings made with any Regulatory Authority related to Ocular Products (including IND number 100786), (B) any agreements which relate to clinical trials of Ocular Products, or (C) any agreement related to the manufacture, supply or distribution of, or which otherwise relate to, Ocular Products or other products outside the Field.

Appears in 1 contract

Samples: License Agreement (Lpath, Inc)

Technology Transfer. Subject to The Parties shall discuss and agree in writing in an executable proposal the terms exact scope of the Development Supply AgreementTechnology Transfer services Patheon is to provide and the costs to be charged by Patheon in providing these services based on the rates set out below pursuant to Section 2.1 (p). All Fees stated in this Schedule F are fees applicable as at 1st November 2012. Accordingly, the fees applicable as soon 1st November 2013 shall be those fees stated in this Schedule F adjusted to reflect the increase or decrease in the United Kingdom Retail Price Index (All Items) published by the National Institute for Statistics (as reasonably practicable, but published at: xxx.xxxxxxxxxx.xxx.xx) in no event later than the fifth (5th) anniversary respect of the Effective Date, Alnylam shall initiate a period from 1st November 2012 to 30 October 2013. Programme Management Examples of activities here might include but are not limited to: •Support for the generation of Technology Transfer Protocols •Support for cross-organization technology transfer to MedCo, or to its Third Party manufacturer(s) teams •Support implementation of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within activities Patheon will invoice Zogenix at a rate of [***] days after receipt per hour for these activities. Process Development Examples of an activities here might include but are not limited to: •Review and update applicable process development reports •Suggest parameters and metrics that support successful tech transfer •Provide on-site assistance at third party as necessary Patheon will invoice thereforZogenix at a rate of [***] per hour for all onsite activities. Alnylam Patheon will invoice Zogenix at a rate of [***] per day for all off site activities. In addition all documented travel expenses will be paid that are approved by Zogenix in advance in writing and its Affiliates shall keep complete are in accord with Patheon’s company travel policy for travel for a similar purpose by the same employee Manufacturing Examples of activities here might include but are not limited to: •Escorting agreed Zogenix or third party visitors to observe the at Patheon •Supply master batch records, SOPs maintenance and accurate records use logs and provide in sufficient detail machine-readable formats •Provide recommendation for changes •Assist with process fit analyses •Input into summaries of manufacturing experience to enable date –Supply in process results to date *** Certain information on this page has been omitted and filed separately with the payments payable hereunder Commission. Confidential treatment has been requested with respect to be determinedthe omitted portions. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage –Supply processing parameters from cGMPs runs •Identify any critical process parameters Patheon will invoice Zogenix at a rate of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely [***] per hour all activities related to the manufacture provision of Licensed Productscopies of documents. Such assignment shall Patheon will invoice Zogenix [***] per hour for all escorting duties. Patheon will invoice Zogenix at a rate of [***] per hour for all other on site activities. Patheon will invoice Zogenix at a rate of [***] per day for all off site activities. In addition all documented travel expenses will be subject paid by Zogenix that are approved in advance in writing and are in accord with Patheon’s company travel policy for travel for a similar purpose by the same employee. Materials Management Examples of activities here might include but are not limited to: • Provide xxxx of materials, resources and routings in machine-readable formats –Current and for manufactured batches •List of raw material vendors and current specifications •List of any Patheon-specific materials •List of any proprietary reagents •List of any supply agreements Patheon will invoice Zogenix at a rate of [***] per hour all activities related to the terms and conditions provision of such agreementcopies of documents. Patheon will invoice Zogenix at a rate of [***] per hour for all other activities. Quality Control Examples of activities here might include but are not limited to: •Support generation of assay transfer package –Assay methods –Qualification protocols –Reagent list, including sources •Collaborate on assay transfer protocol •Allow on site observation of methods •Perform necessary practical assay transfer assistance at third party Patheon will invoice Zogenix at a rate of [***] per hour all activities related to the provision of copies of documents. Patheon will invoice Zogenix at a rate of [***] per hour for all other activities. Quality Assurance Examples of activities here might include but are not limited to: *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. •Review of all documents to ensure that they are the latest version –Process description –Batch records, assay methods, –Raw material specifications •Identification of any required consents ancillary documents •Change control of such Third Party Technology Transfer protocol –Assay transfer protocol review and MedCo’s written agreement to assume all the obligations approval Patheon will invoice Zogenix at a rate of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible [***] per hour for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCothese activities.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Zogenix, Inc.)

Technology Transfer. Subject (a) At any time prior to the terms initiation of the Development Supply Agreementfirst Phase III Clinical Trial (subject to Brii Bio’s ability to initiate an earlier transfer of Manufacturing Technology as set forth in Schedule 7.1(a) in the event that VBI is delayed by more than six (6) months in meeting its final deliverable obligations set forth therein) for the Licensed Product in the Licensed Territory, as soon as reasonably practicableBrii Bio may elect to have VBI transfer manufacturing responsibility for clinical supply and commercial supply to a Third Party manufacturer either in the VBI Territory or the Licensed Territory (to the extent permitted by Applicable Law) (the “Third Party Manufacturer”); provided that, but in VBI shall have no event later than obligation to commence such transfer until after the fifth (5th) anniversary Collaboration Clinical Trial has been initiated. Once Brii Bio has elected to have VBI initiate such transfer, then VBI will use Commercially Reasonable Efforts to effect a transfer of the Effective DateManufacturing Technology in accordance with the requirements set forth in this Section 7.2(a), Alnylam including the timeframes set forth in the foregoing sentence. The Parties shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or mutually agree upon such Third Party manufacturer(sManufacturer through the JSC, provided that the selection of such Third Party Manufacturer shall be subject to Brii Bio’s final-decision making authority in accordance with Section 4.4(a). Once such selection has been made, the Parties shall enter into a three (3)-party Supply Agreement with such Third Party Manufacturer for commercial supply of Licensed Products solely to Brii Bio; provided that, VBI’s rights under such Third Party Manufacturer supply agreement shall be limited to ensuring that such Third Party Manufacturer (i) with respect thereto, all at MedComaintains the confidentiality of VBI’s expenseConfidential Information, including any information related to the Costs reasonably incurred by Alnylam in connection VBI Technology, (ii) complies with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within VBI’s obligations under the [***] days after receipt of an invoice therefor. Alnylam **], and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the (iii) complies with applicable Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product specifications and Finished Product)Applicable Laws. Promptly after MedCo’s written request, Alnylam VBI shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of fully enable such Third Party and MedCo’s written agreement Manufacturer to assume all manufacture Licensed Products, including through the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as requirements set forth in this Section 5.37.2(b) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturerbelow. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo.THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”

Appears in 1 contract

Samples: Collaboration and License Agreement (VBI Vaccines Inc/Bc)

Technology Transfer. Subject Prior to manufacturing the terms of the Development Supply AgreementProduct, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Productmanufacturing process will be performed from Purchaser to SWI. Purchaser shall disclose (and provide copies, and shall make available its personnel on a reasonable basis as applicable) to consult with MedCo or such Third Party manufacturer(s) with respect thereto, SWI all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely information related to the manufacture of Licensed Productsthe Product in Purchaser’s possession, that is required for the manufacture of the Product by SWI (collectively “Manufacturing Technology”); provided that any such information is used solely for the purpose of manufacturing the Product in accordance with this Agreement. SWI acknowledges that such Manufacturing Technology is and shall remain the sole property of Purchaser and/or its Affiliates, and nothing herein shall be deemed to convey to SWI any right therein except as required for the purpose of manufacturing the Product in accordance with this Agreement. The steps, planning and obligations of the Parties regarding the transfer of the Manufacturing Technology for such Product are set forth in the technology transfer master plan attached in Exhibit D (the “Technology Transfer Master Plan”). Provided that Purchaser supply SWI with the needed amount of Compound at *** to SWI, SWI will manufacture the required number of Batches as outlined in the Technology Transfer Master Plan and a minimum of *** validation Batches of Product. Purchaser shall be responsible for any and all regulatory requirements with respect to the Product. SWI shall provide to Purchaser data required by Purchaser to qualify SWI’s facility as per the Technology Transfer Master Plan. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Upon request, Purchaser will provide SWI with, assistance or on-site support as may be reasonably required by SWI in connection with the transfer of the manufacturing technology. Such assignment shall assistance will be subject to the terms and conditions provided *** for a number of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer days as set forth in this Section 5.3) for the supply Technology Transfer Master Plan. Purchaser shall support the one-time costs as described in the Technology Transfer Master Plan and purchase from SWI each validation Batch that meets the Specifications at the Price set forth in Exhibit B. If any of such Licensed the validation Batches of a Product and Alnylam does not comply with the Specifications, Supplier shall have no obligations under *** (***) months to re-manufacture and deliver the number of validation Batch(es) that failed to meet the Specifications. If SWI is unable within that *** (***)-month period to manufacture and deliver to Purchaser the validation Batch(es), Section 9.2(c) shall apply. Purchaser will be reimbursed for *** any validation Batches that fail to meet the Specifications, in the event that such agreement between MedCo and such Third Party manufacturerfailure is due to SWI’s mistake, negligence or failure to follow Purchaser’s instructions. Alnylam shall use Commercially Reasonable Efforts In the event any validation batches fail to obtain meet the Specifications for any such consent in a form reasonably acceptable other reason, except for Purchaser’s mistake, negligence or failure to MedCoprovide SWI with any portion of the Manufacturing Technology, SWI will ***.

Appears in 1 contract

Samples: Manufacturing and Supply Agreement (Vivus Inc)

Technology Transfer. Subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology In its transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed ProductTechnology to ATS, CMI shall provide such reasonable training and documentation to ATS to enable ATS to obtain ISO 9002 certification and FDA GMP/QSR approval of the Production Line and the Licensed Product made thereon. To the extent that CMI documentation ("CMI Documentation") for the Licensed Technology is to be transferred hereunder, CMI shall provide one (1) legible hard copy of each manual or other documentation package or the electronic files thereof in Microsoft Word or Excel format or such other computer-aided design data used by CMI to manufacture Licensed Product in a format readable using commercially available software. CMI hereby grants ATS a non-exclusive, royalty-free, worldwide license to make, distribute and use such internal copies and derivative works of the CMI Documentation as are reasonably necessary to use the Licensed Technology for the purposes hereof, provided each such copy or derivative work shall retain any CMI copyright, trademark or other proprietary notices as are contained in the original version thereof, and shall make available its personnel on a reasonable basis provided further that ATS agrees to consult with MedCo pay any license fees or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam additional software development costs in connection with such herewith. Within ninety (90) days of the effective date of this Agreement, the parties shall adopt a mutually acceptable training and technology transfer activitiesplan to enable selected ATS managers, engineers and other staff to acquire and master the Licensed Technology, including, where appropriate, a system for CMI to "train the trainers." After the third anniversary date of this Agreement, CMI may notify ATS in writing that it is ready to initiate its transfer to ATS of the Licensed Technology, equipment and machining specifications and operating capability to permit ATS to develop the capability to internally machine graphite parts (the "Graphite Capability"), machine pyrolytic carbon coated parts (the "Pyrolytic Carbon Capability"), and develop its own tooling parts (the "Tooling Capability") (the date of such notification respectively referred to herein as the "Graphite Notice Date", the "Pyrolytic Carbon Notice Date" and the "Tooling Notice Date"). MedCo ATS shall reimburse Alnylam notify CMI in writing within thirty (30) business days of the Graphite Notice Date, the Pyrolytic Carbon Notice Date and the Tooling Notice Date, as applicable, whether it intends to proceed to develop the Graphite Capability, the Pyrolytic Carbon Capability, or the Tooling Capability, as applicable (respectively the "Graphite Decision Date", the "Pyrolytic Carbon Decision Date"and the "Tooling Decision Date"). If ATS fails to provide such Costs incurred with respect a notification, such action shall be deemed to be a decision not to develop such Manufacturing technology capability. After the third anniversary date of this Agreement, ATS may notify CMI in writing that it is ready to receive transfer to ATS of the Graphite Capability, the Pyrolytic Carbon Capability, and the Tooling Capability. CMI will use its best efforts to commence transfer of such capability within [***] days six (6) months after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedConotice from ATS.

Appears in 1 contract

Samples: Carbon Agreement (Ats Medical Inc)

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